Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Eli Lilly and Company200 enrolled

Overview

The purpose of this study is to evaluate the function of the bladder and urethra during urinary storage or voiding in men with signs and symptoms of benign prostatic hyperplasia treated with either placebo or tadalafil.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Benign Prostatic Hyperplasia

Interventions

TadalafilDRUG

20 mg tadalafil tablet taken by mouth once a day for 12 weeks.

PlaceboDRUG

Placebo tablet taken by mouth once a day for 12 weeks.

Eligibility

Sex: MALEMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men 40 years of age or older with Lower Urinary Tract Symptoms (LUTS) with a total International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 1. * Agree not to use any other approved or experimental medications for Benign Prostate Hyperplasia (BPH)-Lower Urinary Tract Symptoms, including alpha blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, or herbal preparations at any time during the study. * Have not taken finasteride or dutasteride therapy for at least 4 months prior to Visit 2; have not taken any other LUTS therapy (including herbal preparations) or PDE5 inhibitors for at least 4 weeks prior to Visit 2. * Have had BPH-LUTS for greater than 6 months prior to Visit 1. Exclusion Criteria: * Any pelvic surgical procedure on the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery. * History of urethral obstruction due to stricture, valves, sclerosis, or tumor. * Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease, multiple sclerosis). * History of cardiac conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study. * History of angina requiring treatment with nitrates. * Prostate Specific Antigen (PSA) greater than 10 nanogram/milliliter (ng/ml) at Visit 1.

Locations (13)

Outcomes

Primary Outcomes

Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax)

Time frame: Baseline and 12 weeks

Secondary Outcomes

Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies

Qmax was measured during free-flow tests using a standard calibrated flow meter.

Time frame: Baseline and 12 weeks

Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies

Qave was measured during free-flow tests using a standard calibrated flow meter.

Time frame: Baseline and 12 weeks

Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies

Time frame: Baseline and 12 weeks

Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies

PVRcath is the volume of urine remaining int he bladder after voiding, measured by catheterization.

Time frame: Baseline and 12 weeks

Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies

Total bladder capacity was defined as Vcomp + PVRcath (obtained when the bladder was full).

Time frame: Baseline and 12 weeks

Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies

Bladder voiding efficiency was defined as (Vcomp/total bladder capacity) X 100 (obtained when the bladder was full).

Data from ClinicalTrials.gov

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Newport Beach, California, United States

Tarzana, California, United States

Middlebury, Connecticut, United States

Orlando, Florida, United States

Chicago, Illinois, United States

Fort Wayne, Indiana, United States

Garden City, New York, United States

San Antonio, Texas, United States

Pátrai, Greece

Thessaloniki, Greece

...and 3 more locations

Time frame: Baseline and 12 weeks

Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies

Qmax was measured duirng pressure-flow tests.

Time frame: Baseline and 12 weeks

Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies

Qave was measured during pressure-flow tests.

Time frame: Baseline and 12 weeks

Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies

Vcomp was defined as the volume of voided urine measured during pressure-flow tests.

Time frame: Baseline and 12 weeks

Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies

Max Pdet was defined as the maximum detrusor pressure observed during voiding.

Time frame: Baseline and 12 weeks

Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies

BCI was derived from the equation PdetQmax + 5Qmax. Scores: \<100 means weak, 100-150 menas normal, \>150 means strong. A decrease means a decrease in contractility of the bladder.

Time frame: Baseline and 12 weeks

Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies

BOOI, formerly known as the Abrams-Griffith number, was derived from the equation PdetQmax - 2Qmax. Scores: \<20 means unobstructed, 20-40 means equivocol, \>40 means obstructed. An increase means worsening of obstruction, a decreased means lessening of obstruction (improvement).

Time frame: Baseline and 12 weeks

Presence of Involuntary Detrusor Contractions During Bladder Filling

Time frame: Baseline and 12 weeks

Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction

Assessed in participants with involuntary detrusor contractions during the bladder filling at both baseline and endpoint.

Time frame: Baseline and 12 weeks

Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score

The IPSS Total Score is obtained by combining the scores of the responses to the 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.

Time frame: 12 weeks

Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests

Laboratory tests that were statistically significant and clinically adverse would be reported for safety.

Time frame: Baseline and 12 weeks